Cross-linking of Corneal Collagen (CXL) With Ultraviolet-A in Asymmetric Corneas
NCT ID: NCT01189864
Last Updated: 2018-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
3493 participants
OBSERVATIONAL
2010-02-01
2017-02-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Ciprofloxicin or Vigamox or other.
Ciprofloxicin or Vigamox or other.
Ciprofloxicin or Vigamox or other to be used qid till epithelialized.
Nonsteroidal (Acular, Voltaren Xibrom, etc)
Nonsteroidal (Acular, Acuvail, Voltaren Xibrom, etc)
Nonsteroidal (Acular, Voltaren Xibrom, etc) qid up to 5-10 days post-op
Steroid (FML, Pred Forte, Flarex, etc.)
Steroid (FML, Pred Forte, Flarex, etc.)
Steroid (FML, Pred Forte, Flarex, etc.) to be used qid to qd for 1-8 weeks.
Interventions
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Ciprofloxicin or Vigamox or other.
Ciprofloxicin or Vigamox or other to be used qid till epithelialized.
Nonsteroidal (Acular, Acuvail, Voltaren Xibrom, etc)
Nonsteroidal (Acular, Voltaren Xibrom, etc) qid up to 5-10 days post-op
Steroid (FML, Pred Forte, Flarex, etc.)
Steroid (FML, Pred Forte, Flarex, etc.) to be used qid to qd for 1-8 weeks.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of keratoconus, FFKC, post-LASIK ectasia, or pellucid marginal degeneration or forme fruste pellucid marginal degeneration (FFPMD).
* Diagnosis of FFKC
* History of Radial Keratotomy with fluctuating vision
* Ability to provide written informed consent
* Likely to complete all study visits
* Minimum corneal thickness of at least 300 Measured by ultrasound or Pentacam
* At least 6 months since last corneal surgery (Intacs/PRK/LASIK/Epi-LASIK/LASEK)
Exclusion Criteria
* Contraindications to any study medications or their components
* Pregnancy or breast feeding
* Active Herpes Corneal Disease
12 Years
ALL
No
Sponsors
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Cxlusa
INDUSTRY
Responsible Party
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Principal Investigators
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William Trattler, MD
Role: PRINCIPAL_INVESTIGATOR
The Center for Excellence in Eye Care
Jodi Luchs, MD
Role: PRINCIPAL_INVESTIGATOR
South Shore Eye Care LLP
Shamik Bafna, MD
Role: PRINCIPAL_INVESTIGATOR
Cleveland Eye Clinic
Parag Majmudar, MD
Role: PRINCIPAL_INVESTIGATOR
Chicago Cornea Consultants, LTD
Jay Schwartz, MD
Role: PRINCIPAL_INVESTIGATOR
Schwartz Laser Eye Center
Jonathan Davidorf, MD
Role: PRINCIPAL_INVESTIGATOR
Davidorf Eye Group
Daniel Goodman, MD
Role: PRINCIPAL_INVESTIGATOR
Goodman Eye Center
Jonathan Talamo, MD
Role: PRINCIPAL_INVESTIGATOR
Talamo Laser Eye Center
Sandy Feldman, MD
Role: PRINCIPAL_INVESTIGATOR
Clear View Eye & Laser Medical Center
Gregg Berdy, MD
Role: PRINCIPAL_INVESTIGATOR
Ophthalomology Associates
Lance Forstot
Role: PRINCIPAL_INVESTIGATOR
Corneal Consultants of Colorado, P.C
Mark Kontos, MD
Role: PRINCIPAL_INVESTIGATOR
Empire Eye Physicians
Audrey Rostov, MD
Role: PRINCIPAL_INVESTIGATOR
Northwest Eye Surgeons
John Hovanesian, MD
Role: PRINCIPAL_INVESTIGATOR
Harvard Eye Associates
Locations
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Schwartz Laser Eye Center
Scottsdale, Arizona, United States
Harvard Eye Associates
Laguna Hills, California, United States
Clear View Eye & Laser Medical Center
San Diego, California, United States
San Francisco, California, United States
Davidorf Eye Group
West Hills, California, United States
Corneal Consultants of Colorado, P.C
Littleton, Colorado, United States
The Center for Excellence in Eye Care
Miami, Florida, United States
Chicago Cornea Consultants, LTD
Hoffman Estates, Illinois, United States
TLC Laser Eye Center
Rockville, Maryland, United States
Talamo Laser Eye Center
Waltham, Massachusetts, United States
Ophthalomology Associates
St Louis, Missouri, United States
South Shore Eye Care LLP
Wantagh, New York, United States
Cleveland Eye Clinic
Brecksville, Ohio, United States
TLC Laser Eye Center
Fairfax, Virginia, United States
Northwest Eye Surgeons
Seattle, Washington, United States
Empire Eye Physicians
Spokane Valley, Washington, United States
Countries
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Other Identifiers
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CXL (12 & older)
Identifier Type: -
Identifier Source: org_study_id
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